US8808372B2ActiveUtilityA1

Breast implant spacers for the treatment of periprosthetic breast implant infections

78
Assignee: KLEBUC MICHAELPriority: Apr 27, 2012Filed: Apr 27, 2012Granted: Aug 19, 2014
Est. expiryApr 27, 2032(~5.7 yrs left)· nominal 20-yr term from priority
Inventors:Michael KlebucElizabeth Ann Welter
B29C 33/505B29C 45/0001B29C 39/003B29K 2083/00B29C 45/4421B29C 33/40B29K 2995/0056B29C 43/02B29L 2031/7532A61F 2/12A61F 2250/0067A61F 2220/0091A61F 2230/0091A61M 31/002A61L 24/00A61F 2230/0071A61F 2220/0075A61F 2240/001A61F 2250/0059A61M 31/00A61L 2430/04A61L 2300/406A61F 2230/0067A61L 27/54A61L 2300/408
78
PatentIndex Score
6
Cited by
41
References
38
Claims

Abstract

The present disclosure provides improved devices and methods to treat periprosthetic breast implant infections.

Claims

exact text as granted — not AI-modified
What is claimed: 
     
       1. A breast implant spacer comprising a cement and an antibiotic, antifungal, bacteriostatic or bacteriocidal agent, or a combination thereof, wherein the spacer comprises a plurality of segments that are connected by at least a first pivot pin, a wire, or a spring. 
     
     
       2. The breast implant spacer of  claim 1 , wherein the spacer is designed to substantially resemble a breast implant. 
     
     
       3. The breast implant spacer of  claim 1 , wherein the spacer is designed to have a comparable volume or a comparable shape of a breast implant. 
     
     
       4. The breast implant spacer of  claim 1 , wherein the plurality of segments are connected by at least a first pivot pin. 
     
     
       5. The breast implant spacer of  claim 4 , wherein the at least a first pivot pin comprises a polymer, an acrylic cement, a metal, or a combination thereof. 
     
     
       6. The breast implant spacer of  claim 5 , wherein the at least a first pivot pin comprises a polymer. 
     
     
       7. The breast implant spacer of  claim 6 , wherein the at least a first pivot pin comprises ultra-high molecular weight polyethylene, high density polyethylene, acetal homopolymer, polyetheretherketone, acetal polyoxymethylene copolymer, acrylonitrile butadiene styrene, fluorinated ethylene propylene, polytetrafluoroethylene linked to mica, polytetrafluoroethylene, ethylene tetrafluoroethylene, polyphenylene sulfide, polyphenylsulfone, polyethyleneimine, polysulfone, polyethersulfone, polycarbonate, poly(p-phenylene oxide), or a combination thereof. 
     
     
       8. The breast implant spacer of  claim 5 , wherein the at least a first pivot pin comprises a metal. 
     
     
       9. The breast implant spacer of  claim 8 , wherein the at least a first pivot pin comprises stainless steel, titanium, cobalt chromium, or a combination thereof. 
     
     
       10. The breast implant spacer of  claim 5 , wherein the at least a first pivot pin comprises an acrylic cement. 
     
     
       11. The breast implant spacer of  claim 10 , wherein the acrylic cement is loaded with an antibiotic. 
     
     
       12. The breast implant spacer of  claim 4 , wherein the plurality of segments are connected by a first pivot pin and a second pivot pin. 
     
     
       13. The breast implant spacer of  claim 1 , wherein the plurality of segments are connected by a wire. 
     
     
       14. The breast implant spacer of  claim 13 , wherein the wire comprises stainless steel, DFT®, titanium or a titanium alloy, tantalum, a copper-manganese, copper-nickel, nickel-chromium or quaternary resistance alloy, a mechanical alloy, an austenitic nickel-chromium based superalloy, a HASTELLOY® corrosion-resistant superalloy, or a shape-memory alloy. 
     
     
       15. The breast implant spacer of  claim 14 , wherein the wire comprises a shape-memory alloy. 
     
     
       16. The breast implant spacer of  claim 15 , wherein the shape-memory alloy is a copper-zinc-aluminum-nickel, copper-aluminum-nickel, or nickel-titanium shape-memory alloy. 
     
     
       17. The breast implant spacer of  claim 1 , wherein the plurality of segments are connected by a spring. 
     
     
       18. The breast implant spacer of  claim 17 , wherein the spring comprises stainless steel, DFT®, titanium or a titanium alloy, tantalum, a copper-manganese, copper-nickel, nickel-chromium or quaternary resistance alloy, a mechanical alloy, an austenitic nickel-chromium based superalloy, a HASTELLOY® corrosion-resistant superalloy, or a shape-memory alloy. 
     
     
       19. The breast implant spacer of  claim 18 , wherein the spring comprises stainless steel. 
     
     
       20. The breast implant spacer of  claim 1 , further comprising a template. 
     
     
       21. The breast implant spacer of  claim 20 , wherein the template comprises a biocompatible polymer or a metal. 
     
     
       22. The breast implant spacer of  claim 21 , wherein the template comprises a biocompatible polymer. 
     
     
       23. The breast implant spacer of  claim 22 , wherein the template comprises ultra-high molecular weight polyethylene, high density polyethylene, acetal homopolymer, polyetheretherketone, acetal polyoxymethylene copolymer, acrylonitrile butadiene styrene, fluorinated ethylene propylene, polytetrafluoroethylene linked to mica, polytetrafluoroethylene, ethylene tetrafluoroethylene, polyphenylene sulfide, polyphenylsulfone, polyethyleneimine, polysulfone, polyethersulfone, polycarbonate, poly(p-phenylene oxide), or a combination thereof. 
     
     
       24. The breast implant spacer of  claim 21 , wherein the template comprises a metal. 
     
     
       25. The breast implant spacer of  claim 24 , wherein the template comprises stainless steel, titanium, cobalt chromium, or a combination thereof. 
     
     
       26. The breast implant spacer of  claim 1 , wherein the breast implant spacer comprises a suture hole. 
     
     
       27. The breast implant spacer of  claim 1 , wherein at least two of the plurality of segments comprise a suture hole. 
     
     
       28. The breast implant spacer of  claim 1 , wherein the breast implant spacer is created from a mold. 
     
     
       29. The breast implant spacer of  claim 28 , wherein the mold comprises a medical grade plastic or silicone, ultra-high molecular weight polyethylene, high density polyethylene, acetal homopolymer, acetal polyoxymethylene copolymer, or a combination thereof. 
     
     
       30. The breast implant spacer of  claim 28 , wherein the breast implant spacer is created from an injectable mold. 
     
     
       31. The breast implant spacer of  claim 30 , wherein the injectable mold comprises a medical grade plastic or silicone. 
     
     
       32. The breast implant spacer of  claim 1 , wherein the cement is a poly-methyl-methacrylate cement, a methyl-methacrylate-styrene copolymer cement, or a methyl-methacrylate-methyl acrylate cement. 
     
     
       33. The breast implant spacer of  claim 32 , wherein the cement is a poly-methyl-methacrylate cement. 
     
     
       34. The breast implant spacer of  claim 1 , wherein said antibiotic, antifungal, bacteriostatic or bacteriocidal agent does not degrade upon the cement setting. 
     
     
       35. The breast implant spacer of  claim 34 , wherein the antibiotic, antifungal, bacteriostatic or bacteriocidal agent is vancomycin, tobramycin, voriconazole, gentamicin, erythromycin, oxacillin, cloxacillin, methicillin, lincomycin, ampicillin, colistin, clindamycin, a cephalosporin, amphotericin B, fluconazole, copper-nitride, metallic silver, or any combination thereof. 
     
     
       36. The breast implant spacer of  claim 35 , wherein the antibiotic, antifungal, bacteriostatic or bacteriocidal agent is vancomycin, tobramycin, voriconazole, or any combination thereof. 
     
     
       37. A breast implant spacer comprising plurality of segments, each of said segments comprising a poly-methyl-methacrylate cement and vancomycin, tobramycin, voriconazole, or any combination thereof, said plurality of segments connected by a first pivot pin and a second pivot pin. 
     
     
       38. A breast implant spacer comprising plurality of segments, each of said segments comprising a poly-methyl-methacrylate cement and vancomycin, tobramycin, voriconazole, or any combination thereof, said plurality of segments connected by a spring.

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